Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee

Completed

Conditions studied: Defect of Articular Cartilage

In brief

Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage. During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage. This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not. The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.

Key facts

Study ID

NCT02203071

Run by

University of Missouri-Columbia

People needed

25

Starts

2014-06-01

Expected to finish

2018-09-01

Last updated by the study team

2020-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• I. Inclusion in the study will be considered when all of the following conditions are met:
• The subject is a candidate for the use of a MSP with microfracture and PRP, with or without augmentation with BioCartilage, for treatment of a focal defect of the knee (trochlea or femoral condyle).
• The subject is 18-years of age or greater
• The subject is able and willing to consent to participate in the study
• The subject is expected to be able to safely undergo MRI at the 1-year follow-up visit (no contraindications present, such as metal implants)
• Infection or inflammatory arthropathy (such as rheumatoid arthritis) is absent in the operative knee

You may not qualify if…

• II. Exclusion from the study will be determined by any one of the following conditions being met:
• The subject is undergoing bilateral knee surgery
• The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
• The subject is either pregnant, or a prisoner

Where it is running

• Missouri Orthopaedic Institute — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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